The FDA’s Role with Radiation Emitting Products

by | Oct 23, 2023 | CDRH, Compliance, FDA, Radiation, Staff Augmentation

Everyone knows that the FDA regulates medical products in the US, but did you know that the FDA also regulates radiation-emitting products, even if they aren’t a medical device or pharmaceutical? That’s right, any electronic product that generates any kind of radiation is a product that the FDA regulates and has governance over. This can span from the microwave in your kitchen, to laser light shows, and everything in between. This blog will give an introductory overview of the FDA’s role with radiation-emitting electronic products.

The FDA’s regulatory authority over radiation-emitting electronic products directly from the FD&C Act. The FDA’s CDRH (Center for Devices and Radiological Health) regulates both medical devices, and non-medical electronic devices that produce radiation. It’s important to note that as a general rule, the FDA regulates the manufacture and distribution of these products, while individual states regulate the actual use of the products. The FDA’s purpose is to protect the public from hazardous exposure to radiation from electronic products.

21 CFR § 1000-1050 is where you’ll find the regulations for manufacturers of radiation-emitting products. These regulations cover topics such as annual product submissions and adverse event reporting, just to name a couple. As with medical devices/pharmaceuticals, these regulations also govern any products manufactured internationally, but imported and marketed in the US. Also, like medical devices, manufacturers of radiation-emitting products are required to maintain records and submit reports to CDRH. One of these reports is similar to medical device pre-market submissions, although with significantly less evidence burden and is more of a notification to the FDA, and less of a request for marketing clearance or approval. Once you submit your product report to the FDA, it will be assigned an accession number, which is a unique identification number that is required to be included in all communication regarding the product. The accession number will hold all of the traceability that your product has been reviewed by the FDA and is in compliance with all of the applicable regulatory requirements.

The FDA’s role in electronic/radiation-emitting products can lead to confusion. The FDA doesn’t regulate every electronic product, just those that emit any form of radiation. This is in alignment with the FDA’s goal to protect and promote public health, as radiation exposure can definitely impact public health. It’s also important to note that the FDA doesn’t regulate every radioactive material, as there are a number of government agencies that hold that power (such as the EPA, NRC, and NIOSH).

EMMA International can help bring your electronic radiation-emitting product to market, give us a call at 248-987-4497 or email today to learn more!

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